NA 02.214.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982055507), received between Jun 7, 2019 and Nov 18, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827264 ↗
• MalfunctionMar 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION OF 3-4 METACARPALS ON LEFT HAND, THE SURGEON PUT IN TWO (2) SCREWS IN THE PLATE ON THE METACARPAL WITH NO ISSUE. THEN THE TWO (2) DRILL BIT BROKE AND THE BROKEN ENDS LODGED IN THE CANAL OF THE BONE. THE SURGEON WAS ABLE TO GET ONE BROKEN END OUT. HE COULD NOT RETRIEVE THE OTHER BROKEN DRILL BIT PIECE. THEN THE SURGEON HAD A SCREWDRIVER BLADE BREAK UPON INSERTING A SCREW. AND LATER HE HAD ANOTHER SCREW HEAD BREAK AS HE INSERTED THE SCREW. THERE WAS A DELAY OF SURGERY OF SIXTY (60) MINUTES AS THE SURGEON RETRIEVED BROKEN PIECES AND TRIED TO USE OTHER IMPLANTS TO COMPLETE THE SURGERY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS FOR REPORT (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9808466 ↗
• InjuryJun 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE METACARPALS. WHILE COVERING A CASE, ONE (1) 1.5MM/16MM CORTEX SCREW SELF TAPPING AND ONE (1) 1.5MM/12MM CORTEX SCREW SELF TAPPING BROKE WHILE INSERTING AND AS WELL AS ONE (1) DRILL BIT BROKE. SCREW HEADS SNAPPED OFF AND SURGEON BURRED THE SCREW DOWN SO IT WAS FLUSH. A DRILL BIT ALSO BROKE. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE BUT WAS NOT EASILY REMOVED. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH SOME PLIERS AND COULD NOT GET IT OUT AND CHOSE TO BURR THE PROUD PORTION OF THE SCREW SO THE FRAGMENT WAS FLUSH WITH BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 - 20 MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.5MM CORTEX SCREW SELF TAPPING 16MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8680008 ↗